ObjectiveTo explore the correlation between the blood stasis score of coronary heart disease（CAD） and mild cognitive impairment（MCI）， as well as the changes in plasma metabolic profile of blood stasis in patients with CAD combined with MCI（CADMCI） through a cross-sectional study， and further explore the impact of different degrees of blood stasis on the plasma metabolite profile of CADMCI patients. MethodsAccording to the diagnostic criteria of CAD and CAD blood stasis， patients hospitalized in Xiyuan Hospital of China Academy of Chinese Medical Sciences from October 2022 to October 2023 were continuously included. According to the Montreal Cognitive Assessment（MoCA） scale score， the enrolled patients were divided into CADMCI blood stasis group and CAD blood stasis group. The association between blood stasis score and MCI was analyzed by multivariate Logistic regression model. The receiver operating characteristic（ROC） curve was drawn， and the area under the curve（AUC） was calculated to evaluate the sensitivity and specificity of the model. According to the blood stasis score， the first 30 patients in the CADMCI blood stasis group and CAD blood stasis group were divided into mild blood stasis and severe blood stasis. Ultra performance liquid chromatography-quadrupole-time-of-flight mass spectrometry（UPLC-Q-TOF-MS/MS） was used to detect plasma metabolites in each group of patients. The differential metabolites were screened according to variable importance in the projection（VIP） value≥1， fold change（FC）<0.67 or >1.5， and P<0.05. ROC curve analysis was further used to evaluate the discriminatory efficiency of the screened differential metabolites for each group of samples. ResultsA total of 266 CAD patients were included in this study. Multivariate Logistic regression analysis showed that the CAD blood stasis score was significantly correlated with MCI［odds ratio（OR）=1.619， 95% confidence interval（CI） 1.223-2.142， P<0.001， ROC curve AUC was 0.615（95% CI 0.547-0.683， P=0.001）］， indicating that the CAD blood stasis score has a certain predictive value for MCI. Plasma non-targeted metabolomics analysis showed that the main differential metabolites between CAD blood stasis and CADMCI blood stasis were lipid metabolites， among which phosphatidylcholine［20∶4（5Z， 8Z， 11Z， 14Z）/P-18∶1（11Z）］ had the best discriminatory efficiency（ROC curve AUC=0.867， 95% CI 0.754-0.942）. Further analysis of the differential metabolites between mild and severe blood stasis showed that lipid metabolites were also the main differential metabolites between mild and severe blood stasis. Among them， 1α，25-dihydroxy-2β-（2-hydroxyethoxy） vitamin D₃ had the best efficacy in distinguishing mild and severe CAD blood stasis（AUC=0.813， 95% CI 0.649-0.951）， and phosphatidylcholine 34∶2 had the best efficacy in distinguishing mild and severe CADMCI blood stasis（AUC=0.819， 95% CI 0.640-0.941）. ConclusionThere is a significant correlation between CAD blood stasis score and MCI. Phosphatidylcholine metabolites play an important role in the pathogenesis of CADMCI blood stasis and severe blood stasis. The CAD blood stasis score combined with the detection of phosphatidylcholine metabolites can provide a reference for the development of early and efficient identification strategies for CADMCI.

Objective: To validate the analytical performance, operational performance, and process control measures of a domestic fully automatic nucleic acid testing (NAT) system, thereby ensuring an efficient and orderly blood screening workflow. Methods: The concordance rate and sensitivity of WanTag-Vortex Plus system were verified using WHO standard reference panels of HIV-1, HCV and HBV, while precision was assessed using weak positive samples of HIV-1, HCV and HBV. As for its operational performance evaluation, cross-contamination resistance was assessed using strong positive samples, and throughput and stress testing were conducted using negative samples. Reagent stability was verified using weak positive samples, and inter-system performance consistency was assessed using verification panels. In addition, the process control measures were verified using the laboratory quality control demand scale. Results: 1) Verification of concordance rate: The detection results of negative and positive samples of HIV-1, HCV and HBV by WanTag-Vortex Plus system were all consistent with expectations, and the concordance rate was 100%. 2) Precision verification: the repeatability and intermediate precision were extremely high, and the coefficient of variation was less than 5%. 3) Verification of analytical sensitivity: The detection limit of 95% for standard strains of HIV-1, HCV and HBV by WanTag-Vortex Plus system in our laboratory was consistent with the analytical sensitivity provided by reagent manufacturers. 4) Verification of cross-contamination resistance: Five strong positive samples and 87 negative samples were placed according to the actual working conditions and equipment operation design, and the test results were consistent with expectations, with no cross-contamination in the testing system. 5) Throughput and stress testing: Each system completed the individual donor-nucleic acid amplification testing (ID-NAT) of 276 samples in three batches within 12 hours, and successfully completed the ID-NAT test of 828 samples in three consecutive days. 6) Verification of reagent stability: After extreme storage (unsealed storage for 1 week with 4 freeze-thaw cycles), the reagents maintained 100% detection rate in the weak positive samples of HIV-1, HCV, and HBV, showing no significant differences from the control group (Kappa=1). 7) Verification of inter-system performance consistency: The system has stable operation performance, and the performance comparison results across the four devices were consistent (Kappa=1). 8) Process control measures: WanTag-Vortex Plus system software accurately controlled the equipment operation process with strict quality control measures, and correctly interpreted and safely reported the test results. Conclusion: The analytical and operational performance of the WanTag-Vortex Plus system complies with manufacturer design standards and essential laboratory workflow requirements. Integrated with laboratory information system (LIS), the system's control software meets standard process control requirements, yet requires further improvement.

Objective: To validate the analytical performance, operational performance, and process control measures of a domestic fully automatic nucleic acid testing (NAT) system, thereby ensuring an efficient and orderly blood screening workflow. Methods: The concordance rate and sensitivity of WanTag-Vortex Plus system were verified using WHO standard reference panels of HIV-1, HCV and HBV, while precision was assessed using weak positive samples of HIV-1, HCV and HBV. As for its operational performance evaluation, cross-contamination resistance was assessed using strong positive samples, and throughput and stress testing were conducted using negative samples. Reagent stability was verified using weak positive samples, and inter-system performance consistency was assessed using verification panels. In addition, the process control measures were verified using the laboratory quality control demand scale. Results: 1) Verification of concordance rate: The detection results of negative and positive samples of HIV-1, HCV and HBV by WanTag-Vortex Plus system were all consistent with expectations, and the concordance rate was 100%. 2) Precision verification: the repeatability and intermediate precision were extremely high, and the coefficient of variation was less than 5%. 3) Verification of analytical sensitivity: The detection limit of 95% for standard strains of HIV-1, HCV and HBV by WanTag-Vortex Plus system in our laboratory was consistent with the analytical sensitivity provided by reagent manufacturers. 4) Verification of cross-contamination resistance: Five strong positive samples and 87 negative samples were placed according to the actual working conditions and equipment operation design, and the test results were consistent with expectations, with no cross-contamination in the testing system. 5) Throughput and stress testing: Each system completed the individual donor-nucleic acid amplification testing (ID-NAT) of 276 samples in three batches within 12 hours, and successfully completed the ID-NAT test of 828 samples in three consecutive days. 6) Verification of reagent stability: After extreme storage (unsealed storage for 1 week with 4 freeze-thaw cycles), the reagents maintained 100% detection rate in the weak positive samples of HIV-1, HCV, and HBV, showing no significant differences from the control group (Kappa=1). 7) Verification of inter-system performance consistency: The system has stable operation performance, and the performance comparison results across the four devices were consistent (Kappa=1). 8) Process control measures: WanTag-Vortex Plus system software accurately controlled the equipment operation process with strict quality control measures, and correctly interpreted and safely reported the test results. Conclusion: The analytical and operational performance of the WanTag-Vortex Plus system complies with manufacturer design standards and essential laboratory workflow requirements. Integrated with laboratory information system (LIS), the system's control software meets standard process control requirements, yet requires further improvement.

Objective To analyze the distribution characteristics of TCM syndromes in patients with mild cognitive impairment of coronary heart disease(CHD-MCI);To provide reference for the TCM prevention and treatment of CHD-MCI.Methods A prospective,cross-sectional study design was adopted to collect general information and TCM diagnosis information of CHD-MCI patients who attended Xiyuan Hospital of China Academy of Chinese Medical Sciences from July 2022 to December 2023.Descriptive statistics were conducted,retaining the main syndrome entries.Multivariate statistical methods such as factor analysis and clustering analysis were used to enrich and summarize the TCM syndrome characteristics of CHD-MCI patients and analyze their distribution patterns.Results This study collected information on the TCM four diagnostic methods from 220 CHD-MCI patients,retaining clinical syndrome items with a frequency of>20%,including 29 symptoms and 13 tongue pulse information.Common clinical symptoms included chest tightness,thirst,palpitations,chest pain,fatigue,severe physical activity or fatigue,dizziness and soreness in the waist and knees.Common tongue symptoms included greasy tongue coating,yellow tongue coating and dull red tongue.Common pulse conditions included pulse string,sinking pulse and astringency.Factor analysis was conducted on 42 variable items,obtaining 17 common factors with a cumulative contribution rate of 66.298%.Based on this,clustering analysis was applied,combined with clinical diagnosis and treatment experience and expert group opinions,to determine that there were four common types of TCM syndromes in CHD-MCI(ranked from high to low in proportion):kidney deficiency and blood stasis syndrome(38.18%),qi stagnation and blood stasis syndrome(28.18%),heart kidney deficiency syndrome(25.00%)and qi deficiency and phlegm obstruction syndrome(8.64%).Conclusion Patients with CHD-MCI can be classified into four types of TCM syndromes,with kidney deficiency and blood stasis syndrome being the most common.Based on the information from the TCM four diagnostic methods,the key points of each type of syndrome can be determined,providing a basis for the objective classification and differentiation of TCM syndromes in this disease.

Objective:To evaluate the effects of comprehensive intervention on bowel function, anxiety, and quality of life in hospitalized elderly patients, and to assess its safety.Methods:Sixty-four elderly inpatients with mixed-type constipation were recruited between October 2020 and January 2021 and randomly assigned to the treatment group and the control group ( n=32 in each group). The control group received oral mosapride(5 mg each time, 3 times a day) plus one aloe capsule(once a day), whereas the treatment group was provided with a comprehensive intervention including dietary and defecation-behavior guidance, abdominal massage, and psychological support, and additionally took lorazepam(0.5 mg each time, once a day) on top of the control regimen for a 4-week treatment course. Bowel efficacy was recorded at baseline, 2 weeks and 4 weeks after intervention. Anxiety was assessed with the Hamilton anxiety scale (HAMA), and quality of life with the short-form 36 health survey (SF-36). Complications and adverse events were also monitored.SPSS 22.0 software was used for data analysis, and χ2 test or repeated measures ANOVA was used for comparison between the two groups. Results:After 2 and 4 weeks, the overall response rates in the treatment group were 84.37%(27/32) and 93.75%(30/32), respectively, and significantly higher than those in the control group (59.37%(19/32) and 62.50%(20/32); χ2=4.947, 9.143, both P<0.05). HAMA scores decreased from 20.50±2.11 to 14.75± 1.48 in the treatment group and from 20.13±1.60 to 17.75±1.98 in the control group ( Finteraction=18.36, P<0.001). SF-36 total scores improved from 75.82±5.11 to 89.35±5.21 in the treatment group and from 74.90±5.26 to 83.03±5.42 in the control group ( Finteraction=12.74, P<0.001). At both 2 and 4 weeks, the treatment group had lower HAMA scores and higher SF-36 scores than the control group (all P<0.05). The incidence of complications in the treatment group was lower than that in in the control group (6.25%(2/32) vs 37.50%(12/32), χ2=9.143, P<0.05). No serious adverse events occurred in either group. Conclusion:Comprehensive intervention significantly improves functional constipation in elderly inpatients, alleviates anxiety, enhances quality of life, and is well tolerated.

Objective To prepare a stable rat model of chronic liver failure to provide a tool for basic research.Methods Sixty-six SPF SD rats were divided into a normal group(n=18)and a modeling group(n=48).Rats in the modeling group received an intraperitoneal injection of 50％CCl4 olive oil solution(1.5 mL/kg,twice a week).Multidimensional assessment was performed at 8,16,and 24 weeks,respectively,including ultrasonic examination of liver morphology,hardness,portal vein diameter,and ascites,and collection of serum,plasma,and liver tissue to detect liver function,coagulation function,and blood ammonia levels.Liver tissue injury and fibrosis were observed by hematoxylin-eosin(HE)and Masson staining.Cognitive function was assessed using the water maze test.Survival were recorded simultaneously.Results Rats in the model group showed decreased activity and appetite,yellow urine,and increased abdominal circumference compared with the normal group.Ultrasound showed enhanced liver parenchyma echo in the model group that thickened with time,secondary ascites formation,portal vein dilation,and portal hypertension.Water maze and blood ammonia tests confirmed cognitive decline(memory and orientation loss)and hepatic encephalopathy in the model group.Gross observation showed that the liver in the model group was atrophied and appeared rough and uneven.HE staining showed hepatocyte swelling,steatosis,and necrosis,and Masson staining confirmed fibrosis progression with pseudolobule formation.The liver function indexes AST,ALT,TBIL and blood ammonia continued to increase,and coagulation dysfunction(prolonged PT and increased INR)gradually increased with the modeling process.Conclusions Intraperitoneal injection of 50％CCl4 olive oil solution(1.5 mL/kg,every week)for 24 weeks can stably simulate persistent chronic liver injury in rats and lead to the typical pathological changes and complications of chronic liver failure,based on the decompensation stage of cirrhosis.This model replicates the pathological evolution of human hepatitis from liver fibrosis → liver cirrhosis compensation → decompensation → chronic liver failure,providing a reliable modeling reference for the study of the mechanism of chronic liver failure.

To analyze the standard establishment approach and compilation rationale for metallic pharmaceutical packaging standard development in the 2025 edition of the Pharmacopeia of the People's Republic of China.This article systematically explained the background and process of establishing the guiding principles for metallic materials and containers used in pharmaceutical packaging in the Chinese Pharmacopoeia through basic information,relevant domestic and international standards,the establishment of key quality attributes of metallic pharmaceutical packaging materials,and the construction of metallic pharmaceutical packaging material standards.The newly established guidelines,the Pharmacopeia of the People's Republic of China 9625,prioritized product critical quality attributes(CQAs)and real-world applicability.This dual emphasis on rigidity and adaptability enhances drug safety,meets the regulatory requirements,and promotes the globalization and scientific advancement of China's pharmaceutical packaging industry.

Objective:To evaluate the effects of comprehensive intervention on bowel function, anxiety, and quality of life in hospitalized elderly patients, and to assess its safety.Methods:Sixty-four elderly inpatients with mixed-type constipation were recruited between October 2020 and January 2021 and randomly assigned to the treatment group and the control group ( n=32 in each group). The control group received oral mosapride(5 mg each time, 3 times a day) plus one aloe capsule(once a day), whereas the treatment group was provided with a comprehensive intervention including dietary and defecation-behavior guidance, abdominal massage, and psychological support, and additionally took lorazepam(0.5 mg each time, once a day) on top of the control regimen for a 4-week treatment course. Bowel efficacy was recorded at baseline, 2 weeks and 4 weeks after intervention. Anxiety was assessed with the Hamilton anxiety scale (HAMA), and quality of life with the short-form 36 health survey (SF-36). Complications and adverse events were also monitored.SPSS 22.0 software was used for data analysis, and χ2 test or repeated measures ANOVA was used for comparison between the two groups. Results:After 2 and 4 weeks, the overall response rates in the treatment group were 84.37%(27/32) and 93.75%(30/32), respectively, and significantly higher than those in the control group (59.37%(19/32) and 62.50%(20/32); χ2=4.947, 9.143, both P<0.05). HAMA scores decreased from 20.50±2.11 to 14.75± 1.48 in the treatment group and from 20.13±1.60 to 17.75±1.98 in the control group ( Finteraction=18.36, P<0.001). SF-36 total scores improved from 75.82±5.11 to 89.35±5.21 in the treatment group and from 74.90±5.26 to 83.03±5.42 in the control group ( Finteraction=12.74, P<0.001). At both 2 and 4 weeks, the treatment group had lower HAMA scores and higher SF-36 scores than the control group (all P<0.05). The incidence of complications in the treatment group was lower than that in in the control group (6.25%(2/32) vs 37.50%(12/32), χ2=9.143, P<0.05). No serious adverse events occurred in either group. Conclusion:Comprehensive intervention significantly improves functional constipation in elderly inpatients, alleviates anxiety, enhances quality of life, and is well tolerated.

To analyze the standard establishment approach and compilation rationale for metallic pharmaceutical packaging standard development in the 2025 edition of the Pharmacopeia of the People's Republic of China.This article systematically explained the background and process of establishing the guiding principles for metallic materials and containers used in pharmaceutical packaging in the Chinese Pharmacopoeia through basic information,relevant domestic and international standards,the establishment of key quality attributes of metallic pharmaceutical packaging materials,and the construction of metallic pharmaceutical packaging material standards.The newly established guidelines,the Pharmacopeia of the People's Republic of China 9625,prioritized product critical quality attributes(CQAs)and real-world applicability.This dual emphasis on rigidity and adaptability enhances drug safety,meets the regulatory requirements,and promotes the globalization and scientific advancement of China's pharmaceutical packaging industry.

Objective To analyze the distribution characteristics of TCM syndromes in patients with mild cognitive impairment of coronary heart disease(CHD-MCI);To provide reference for the TCM prevention and treatment of CHD-MCI.Methods A prospective,cross-sectional study design was adopted to collect general information and TCM diagnosis information of CHD-MCI patients who attended Xiyuan Hospital of China Academy of Chinese Medical Sciences from July 2022 to December 2023.Descriptive statistics were conducted,retaining the main syndrome entries.Multivariate statistical methods such as factor analysis and clustering analysis were used to enrich and summarize the TCM syndrome characteristics of CHD-MCI patients and analyze their distribution patterns.Results This study collected information on the TCM four diagnostic methods from 220 CHD-MCI patients,retaining clinical syndrome items with a frequency of>20%,including 29 symptoms and 13 tongue pulse information.Common clinical symptoms included chest tightness,thirst,palpitations,chest pain,fatigue,severe physical activity or fatigue,dizziness and soreness in the waist and knees.Common tongue symptoms included greasy tongue coating,yellow tongue coating and dull red tongue.Common pulse conditions included pulse string,sinking pulse and astringency.Factor analysis was conducted on 42 variable items,obtaining 17 common factors with a cumulative contribution rate of 66.298%.Based on this,clustering analysis was applied,combined with clinical diagnosis and treatment experience and expert group opinions,to determine that there were four common types of TCM syndromes in CHD-MCI(ranked from high to low in proportion):kidney deficiency and blood stasis syndrome(38.18%),qi stagnation and blood stasis syndrome(28.18%),heart kidney deficiency syndrome(25.00%)and qi deficiency and phlegm obstruction syndrome(8.64%).Conclusion Patients with CHD-MCI can be classified into four types of TCM syndromes,with kidney deficiency and blood stasis syndrome being the most common.Based on the information from the TCM four diagnostic methods,the key points of each type of syndrome can be determined,providing a basis for the objective classification and differentiation of TCM syndromes in this disease.